Intra-cardiac left atrial and dual support systems

ABSTRACT

A system for treating atrial dysfunction, including heart failure and/or atrial fibrillation, that includes one or more pressurizing elements and control circuitry. The one or more pressurizing elements can comprise one or more balloons and can be configured to be positioned in the left atrium, and optionally the pulmonary artery, of a patient&#39;s heart. The one or more pressurizing elements can be coupled to one or more positioning structures that can be configured to position the one or more pressurizing elements in the left atrium, and optionally the pulmonary artery. The control circuitry can be configured to operate the one or more pressurizing elements to decrease or increase pressure and/or volume in the left atrium, and optionally the pulmonary artery, in accordance with different phases of the cardiac cycle. The control circuitry can be further configured to operate the one or more pressurizing elements to generate coordinated pressure modifications in the left atrium, and optionally the pulmonary artery.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/801,819, filed Feb. 6, 2019, and U.S. Provisional Application No.62/801,917, filed Feb. 6, 2019, the entireties of each of which arehereby incorporated by reference.

BACKGROUND Field of the Invention

The present disclosure generally relates to implantable cardiac devicesand, more particularly, to intra-cardiac left atrial support systems andintra-cardiac dual support systems.

Description of the Related Art

Heart Failure (HF) is a common problem throughout the world and affectsmore than 6.5 million people in the United States alone, a number thatis expected to increase to nearly 8.5 milling by 2030. While many ofthese patients are able to live asymptomatically with chronic HF, everyyear 1.8M patients experience Acute Heart Failure (AHF), a rapidworsening of heart failure symptoms, primarily including dyspnea andfatigue, which requires urgent treatment and immediate hospitalization.In addition to the impact it has on the quality of life for thesepatients, HF treatments and hospitalizations cost the U.S. healthcaresystem over $30B annually. AHF is generally split between twoclassifications, Heart Failure with reduced Ejection Fraction (HFrEF,also referred to as systolic HF) and Heart Failure with preservedEjection Fraction (HFpEF, also referred to as diastolic HF). While bothHFrEF and HFpEF are associated with significant impacts on morbidity andmortality, HFpEF has proven more difficult to address, and despitenumerous efforts to develop therapeutic treatments for the disease,diuretics remain one of the only evidence based therapies to placate theeffects of HFpEF. As such, in addition to opportunities for improvedsolutions for HFrEF and Atrial Fibrillation (AF), there is a significantunmet clinical need to develop a meaningful therapeutic solution forpatients suffering from HFpEF.

At a certain point in the mechanistic and physiological progression ofHF, Left Atrial dysfunction begins to take place. The walls of the LeftAtrium (LA) become stiffer and less compliant leading to a reduction inLeft Atrial reservoir strain (expansion during filling) and activestrain (compression during emptying). This reduction in strain drivesincreased pressure in the Left Atrium which propagates to the lungs(measured by an increase in Pulmonary Capillary Wedge Pressure (PCWP)),reducing lung gas diffusion (measured by diffusion of the lungs forcarbon monoxide (DLCO) and arterial and mixed blood gases), which is thefundamental driver of pulmonary congestion and dyspnea, leading to AHFand hospitalization.

In treating HFrEF, the issue resides with the compromised systolicfunction of the Left Ventricle (LV). As a result, several therapies havebeen developed to assist the left ventricle in generating systemicpressure and systolic flow to support cardiac output (e.g. LVADs).However, since the systolic function and ejection fraction are preservedwith HFpEF, the transference of HFrEF therapies is not well suited oreffective.

Research performed in the last several years has highlighted the role ofthe LA and Left Atrial Pressure in HFpEF. More specifically, researchhas identified Left Atrial dysfunction (e.g., reduced Left AtrialReservoir and Active strains) as an independent risk factor associatedwith HFpEF mortality.

FIG. 1A shows the LA pressure and volume wave forms, which can becombined to depict a “figure-eight” pressure: volume relationship (FIG.1B).

The expansion of the LA during atrial diastole (through ventricularsystole) is known as the reservoir function and is represented by thesegments labeled (1) in FIGS. 1A and 1B. Once the mitral valve opens inearly diastole, LA and LV pressures equalize and blood passively emptiesinto the LV. This is known as the conduit function and is represented bysegment (2) in FIGS. 1A and 1B. Then, at the end of diastole, justbefore the mitral valve closes, the atrium contracts serving the activepump function represented by segments (4) and (5) in FIGS. 1A and 1B.

In the presence of Congestive Heart Failure (CHF) the normal“figure-eight” illustrated in FIG. 1B is driven up and to the right asLA dilation and volume increase is coupled with increasing stiffness andhigher pressures. The increased stiffness also changes the shape of thecurves and reduces reservoir strain (reduced expansion during filling)and pump strain (compression during the atrial systole).

While HFpEF is initially associated with increased LV diastolic fillingpressures, and the inability to fully evacuate the LA, the resultingfluid backup often results in pulmonary congestion and can translate topulmonary hypertension, RV-to-PC (Right Ventricle-pulmonary circulation)uncoupling, and right ventricular overload or dysfunction. Consequently,what begins as left-sided heart failure can often progress toright-sided heart failure. Right-sided affects may be observed as anincrease in Pulmonary Vascular Resistance (PVR), Pulmonary Artery (PA)systolic pressure (which is equivalent to RV systolic pressure),increased RV workload and inefficiency, and reduced Cardiac Output.Increased LA pressure translates to increased pulmonary artery wedgepressure and increased PVR. This results in increased PA systolicpressure and reduced cardiac output during PA diastole due to a decreasein pressure differential. The increased PA systolic pressure translatesto higher workload for the RV during systole and a reduction inefficiency over time.

In response to the role of elevated LA pressure in exacerbating HFpEFsymptoms, intra-atrial devices can be provided that attempt to shuntblood from the LA to the Right Atrium (RA) and thereby reduce LApressure and PCWP. Early clinic studies have shown promising results,but LA shunting does not fully address congestion in the lungs nor doesit help to alleviate the burden on the right side of the heart. Instead,the RA now has to deal with increased volume due to the shunting of theblood from the left side. Furthermore, reducing pressure in the LA alonedoes not address the underlying atrial stiffness and does not help torestore the complete functionality of the LA in all phases of thecardiac cycle. As an example, reducing LA pressure during the activephase of atrial systole does not generate a larger pressure differentialbetween the LA and the LV. As a result LV End Diastolic filling is notoptimized and Cardiac Output is likely to be reduced since volume tisbeing shunted to the right side instead. In addition, LA shunting maynot be as effective in patients suffering from Atrial Fibrillation (AF),which is a common condition in HFpEF patients.

SUMMARY OF THE INVENTION

In some aspects of the disclosure, a system for treating atrialdysfunction is disclosed that comprises a pressurizing element andcontrol circuitry. The pressurizing element can be configured to bepositioned in a left atrium of a heart of a patient. The controlcircuitry can be configured to operate the pressurizing element todecrease a pressure in the left atrium during atrial diastole to drawoxygenated blood out of the lungs of the patient by increasing arelative volume of the left atrium to reduce a filling pressure in theleft atrium and operate the pressurizing element to increase thepressure in the left atrium during atrial systole by reducing therelative volume of the left atrium to increase a left atrial pressureduring atrial systole. The increase in the left atrial pressure duringatrial systole increases a pressure differential between the left atriumand a left ventricle that improves diastolic filling of the leftventricle.

In some aspects, the system can further comprise an atrial positioningstructure coupled to the pressurizing element and configured to positionthe pressurizing element in the left atrium. The atrial positioningstructure can comprise a septal anchor or a left atrial appendageanchor. The atrial positioning structure can comprise a shaft configuredto extend transseptally between a right atrium and the left atrium ofthe heart of the patient. The shaft can be pre-shaped with a curve orbend to facilitate positioning of the pressurizing element in the leftatrium. In some aspects, the system can further comprise a shaped styletconfigured to be delivered through the shaft to facilitate positioningof the pressurizing element in the left atrium.

In some aspects, the pressurizing element can comprise a balloon.Operating the pressurizing element to increase the pressure in the leftatrium can comprise filling the balloon with a liquid or a gas andoperating the pressurizing element to decrease the pressure in the leftatrium can comprise removing the liquid or the gas from the balloon. Thedistal end of the balloon can be recessed within the balloon such thatthe distal end of the balloon is atraumatic. The balloon can comprise anopen central lumen. In some aspects, the system can further comprisepressurizing components that include a pressure chamber and at least onepump disposed between the balloon and the pressure chamber. Thepressurizing components can be configured to be external fixed, externalambulatory, or implantable components.

In some aspects, the atrial positioning structure can comprise a septalanchor. The septal anchor can comprise first and second expandablemembers configured to expand respectively against left and right sidesof an atrial septum of the heart of the patient and the pressurizingelement can be attached to the first expandable member.

In some aspects, the pressurizing element configured to be positioned inthe left atrium can be a first pressurizing element. The system canfurther comprise a second pressurizing element that can be configured tobe positioned in a pulmonary artery of the patient. The secondpressurizing element can be coupled to a pulmonary artery positioningstructure and the pulmonary artery positioning structure can beconfigured to position the second pressurizing element in the pulmonaryartery of the patient. The control circuitry can further be configuredto operate the first and second pressurizing elements to generatecoordinated pressure modifications in the left atrium and the pulmonaryartery. The first pressurizing element can comprise a first balloon andthe second pressurizing element can comprise a second balloon.

In some aspects, a method for treating atrial dysfunction is disclosed.The method can comprise: delivering a pressurizing element into a leftatrium of a patient; operating the pressurizing element to decrease apressure in the left atrium during atrial diastole to draw oxygenatedblood out of the lungs of the patient by increasing a relative volume ofthe left atrium to reduce a filling pressure in the left atrium; andoperating the pressurizing element to increase the pressure in the leftatrium during atrial systole by reducing the relative volume of the leftatrium to increase a left atrial pressure during atrial systole, whereinthe increase in the left atrial pressure during atrial systole increasesa pressure differential between the left atrium and left ventricle thatimproves diastolic filling of the left ventricle.

The method of the preceding paragraph can also include one or more ofthe following features. The pressurizing element can be a balloon. Themethod can further comprise: receiving, at control circuitry from asensor communicatively coupled to the patient, a signal corresponding toa cardiac cycle for the heart of the patient; operating the pressurizingelement to decrease a pressure in the left atrium responsive to aportion of the signal; and operating the pressurizing element toincrease a pressure in the left atrium responsive to an additionalportion of the signal. The sensor can comprise an electrical sensor or apressure sensor. The method can further comprise anchoring thepressurizing element within the left atrium. The pressurizing elementdelivered into the left atrium can be a first pressurizing element, andthe method can further comprise: delivering a second pressurizingelement into a pulmonary artery of the patient; operating the secondpressurizing element to decrease a pressure in the pulmonary arteryduring pulmonary artery systole to reduce pulmonary artery systolicpressures and reduce a work load of a right ventricle of the heart ofthe patient; and operating the second pressurizing element to increase apressure in the pulmonary artery during pulmonary artery diastole aftera pulmonary valve is closed to increase pulmonary artery diastolicpressure to overcome pulmonary vascular resistance and increase cardiacoutput.

In accordance with certain aspects of the disclosure, a system isprovided with an implantable fluid displacing element (e.g., a balloon,a turbine, a pump, or other pressurizing element) that can be operatedto support left atrial operations during various portions of the cardiaccycle. The pressurizing element can be percutaneously positioned andanchored into the left atrium of the heart of a patient. The implantablepressurizing element is operable to support the functionality of theheart through volume displacement and pressure regulation using avariety of programmable timing schemes.

In accordance with certain aspects of the disclosure, a system isprovided with two implantable fluid displacing elements (e.g., balloons,turbines, pumps, or other pressurizing elements) that can be operated incoordination to produce forward and/or backwards flow (e.g., bygenerating pressures and vacuums) during various portions of the cardiaccycle. The two pressurizing elements can be percutaneously positionedand anchored into two separate locations within the heart and/orvasculature of a patient. The two implantable pressurizing elements areoperable and/or programmable to function together or independently withsynchronous timing (e.g., in the case of balloons: both inflated, bothdeflated), exact inverse timing (e.g., for balloons: one inflated whilethe other is deflated, or for an axial pump: one forward while the otheris backwards) or asynchronously with leading or lagging timing betweenthe two different elements in order to support the functionality of theheart through volume displacement and pressure regulation using avariety of programmable timing schemes.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1B illustrate the five phases in the left atrialpressure-volume relationship.

FIG. 2 illustrates a left atrial cardiac support system according tocertain aspects of the present disclosure.

FIG. 3 illustrates a balloon inflation and deflation timeline relativeto various portions of the cardiac cycle in accordance with certainaspects of the present disclosure.

FIG. 4 illustrates the change in left atrial pressure with the use of aleft atrial balloon relative to various portions of the cardiac cycle.

FIG. 5 illustrates perspective views of a left atrial balloon in variousstates in accordance with various aspects of the subject technology.

FIG. 6 illustrates partial cross-sectional views of a left atrialballoon in various states in accordance with various aspects of thesubject technology.

FIG. 7A-7B illustrate a perspective view and a partial cross-sectionalview of a left atrial balloon having a trans-septal shaft and a centrallumen in accordance with various aspects of the subject technology.

FIG. 8 illustrates an implanted trans-septal left atrial positioningstructure and balloon in accordance with various aspects of the subjecttechnology.

FIG. 9 illustrates an implanted left atrial appendage left atrialpositioning structure and balloon in accordance with various aspects ofthe subject technology.

FIGS. 10A-10D illustrate various views of a left atrial balloon inaccordance with various aspect of the subject technology.

FIG. 11 illustrates a schematic of the components of the systems ofFIGS. 2 and 13A-13B in accordance with various aspects of the subjecttechnology.

FIG. 12 illustrates a system with which one or more implementations ofthe subject technology may be implemented.

FIGS. 13A-13B illustrates a dual-sided cardiac support system ininflated and deflated states according to certain aspects of the presentdisclosure.

FIGS. 14-16 illustrate various states of expansion for a pulmonaryartery positioning structure in accordance with various aspects of thesubject technology.

FIG. 17 illustrates an implanted pulmonary artery positioning structurein accordance with various aspects of the subject technology.

FIG. 18 illustrates a system having a spiral-shaped right ventricleballoon in accordance with various aspects of the subject technology.

DETAILED DESCRIPTION

The detailed description set forth below describes variousconfigurations of the subject technology and is not intended torepresent the only configurations in which the subject technology may bepracticed. The detailed description includes specific details for thepurpose of providing a thorough understanding of the subject technology.Accordingly, dimensions may be provided in regard to certain aspects asnon-limiting examples. However, it will be apparent to those skilled inthe art that the subject technology may be practiced without thesespecific details. In some instances, well-known structures andcomponents are shown in block diagram form in order to avoid obscuringthe concepts of the subject technology.

It is to be understood that the present disclosure includes examples ofthe subject technology and does not limit the scope of the appendedclaims. Various aspects of the subject technology will now be disclosedaccording to particular but non-limiting examples. Various embodimentsdescribed in the present disclosure may be carried out in different waysand variations, and in accordance with a desired application orimplementation.

In the following detailed description, numerous specific details are setforth to provide a full understanding of the present disclosure. It willbe apparent, however, to one ordinarily skilled in the art thatembodiments of the present disclosure may be practiced without some ofthe specific details. In other instances, well-known structures andtechniques have not been shown in detail so as not to obscure thedisclosure.

Aspects of this disclosure are directed to systems and methods foratrial dysfunction, including heart failure and/or atrial fibrillation.It should be appreciated that, although the use of systems such assystems 100, 600 are described below for HF applications, the systemscan also be suitable for treatment of non-HF, AF patients based on itsability to restore native LA function and pulsation. Today, it is commonto treat AF through ablation procedures, often referred to as mazeprocedures, whereby the physician uses small incisions, radio waves,freezing, microwave or ultrasound energy to create scar tissue thatdisrupts the electrical circuitry within the LA in an effort toeliminate the fibrillation. This is often effective via surgery but lesseffective when done using the currently available interventionaltechniques. Insufficient ablation could lead to persistent AF while overablation could lead to scarring that causes the LA walls to stiffen andcan ultimately lead to HF. By contrast, using LA balloon 102 asdescribed below to restore LA function (expansion and contraction) couldeliminate the symptoms of AF even in the presence of electricalfluctuations and without the need for ablation that could causeexcessive scarring.

Left Atrial Cardiac Support System

FIG. 2 illustrates an example system 100 in which an implantablepressurizing element has been implanted in the patient. In the exampleof FIG. 2, system 100 includes a pressurizing element 102 implemented asa balloon for illustrative purposes. As shown, an atrial positioningstructure 106 is coupled to the pressurizing element 102 and configuredto position the pressurizing element 102 in a Left Atrium LA of a heart101 of a patient. Although not visible in FIG. 2, system 100 alsoincludes control circuitry configured to operate the pressurizingelement 102 to decrease a pressure in the Left Atrium during atrialdiastole to draw oxygenated blood out of the lungs of the patient bysimulating an increase in left atrial reservoir strain and a relativeincrease in the volume of the Left Atrium to reduce a filling pressurein the Left Atrium. The control circuitry also operates the pressurizingelement 102 to increase the pressure in the Left Atrium during atrialsystole to simulate an increase left atrial active strain by reducingthe relative volume of the Left Atrium to increase left atrial pressureduring atrial systole. The increase in the left atrial pressure duringatrial systole increases a pressure differential between the Left Atriumand Left Ventricle that improves diastolic filling of the LeftVentricle.

A feed line 110 is shown, through which a fluid or a gas can be providedor removed for inflation or deflation of balloon implementations ofpressurizing element 102, or with which control signals can be providedfor operation of other implementations of pressurizing element 102. Thefeed line 110 may be incorporated into or be part of an elongatecatheter body used to deliver the pressurizing element 102 to the LeftAtrium LA. For example, in both balloon and non-balloon embodiments, insome aspects a catheter or sheath may be delivered in a percutaneousapproach through the femoral vein and advanced through the inferior venacava, to the Right Atrium RA, and across the atrial septum into the LeftAtrium LA. The pressurizing element 102 is positioned at a distal end ofthe elongate body and may be expanded in the LA. An expandable atrialpositioning structure 106, shown proximal to the balloon in FIG. 2, mayexpand on the left and/or right sides of the septum to help secure theballoon within the LA. In some embodiments, the catheter body carryingthe balloon may be delivered through a separate trans-septal sheath thatis positioned between the RA and LA.

System 100 may also include one or more sensors such aselectrocardiogram (ECG) sensors and/or pressure sensors that generatesignals that correspond to portions of the cardiac cycle of the patient.Pressurizing element 102 can be operated to generate pressure changes(e.g., pressure increases and/or pressure decreases) in the Left Atrium,in coordination with various portions of the cardiac cycle based on thesignals from the sensor.

In accordance with aspects of the present disclosure, the left-atrialsupport system 100 of FIG. 2 is provided to address potentialdysfunction on the left side of the heart, potentially before problemsoccur on the right side and/or to alleviate dysfunction on both sides ofthe heart via reducing pulmonary capillary wedge pressure (a proxy forpulmonary congestion) and improved filling of the Left Ventricle.

In contrast with HFpEF treatments with devices that reduce LA pressureonly at the cost of increasing the burden on the right side of the heartand decreasing cardiac output, systems 100 as described herein supportthe heart by reducing the burden on the left side of the heart withoutadding burden to the right atrium, thereby potentially also reducingcongestion and pulmonary wedge pressure and improving LV diastolicfilling, which can provide a net increase in cardiac output. This isachieved by placing a fluid/volume displacing system on the left side ofthe heart (e.g., pressurizing element 102 in the Left Atrium). In theexample discussed herein in which pressurizing element 102 isimplemented as a balloon, the inflation and deflation of the balloon istimed in such a way to optimize support for each patient and keep bloodmoving in the proper direction at all times during the cardiac cycle.

Deflation of a balloon 102 in the Left Atrium during atrial diastole canhelp draw oxygenated blood out of the lungs by simulating an increase inLA reservoir strain (e.g., increase in volume during filling) andincreasing the relative volume of the LA and reducing the fillingpressures. Then, by inflating balloon 102 during the active portion ofthe diastolic cycle (e.g., during atrial systole) the balloon cansimulate an increase in pump/active strain by reducing the relativevolume in the LA and increasing LA pressure during the active phase ofthe cycle, thereby increasing the LA-to-LV pressure differential andimproving diastolic filling of the Left Ventricle. This operation of LAballoon 102 serves to restore compliance to areas of the heart (e.g.,the LA and LV) that are experiencing increased stiffness and wallstress.

In various operational scenarios, balloon 102 (or other implementationsof the pressurizing element for fluid/volume displacement in the LA) canbe operated depending on the placement of the balloon and the specificneeds of each patient.

Inflation and deflation of balloon 102 can be based on an initial (e.g.,fixed) timing or can be triggered by sensor signals fromelectrocardiogram (e.g., EKG or ECG) sensors, pressure sensors (e.g., apressure sensor in or near the LA), or a combination thereof.

FIG. 3 shows a waveform 202 illustrating a potential sequence of ballooninflations and deflations for the LA balloon 102 against the timing ofan ECG signal 200.

In one exemplary implementation of the timing for balloon 102 that cangenerate the waveforms of FIG. 3, the LA balloon 102 is triggered todeflate upon detection of the R peak plus a time delay (e.g., a 100millisecond delay after the R peak). In this way, the system initiatesdeflation of the LA balloon 102 such that deflation of the LA ballooncoincides with the natural expansion/reservoir function phase of the LApressure/volume cycle which occurs during ventricular systole when themitral valve is closed. LA balloon inflation can be triggered toinitiate based on the P wave peak of the ECG or the R peak plus anadditional time delay (e.g., a 600 millisecond time delay after the Rpeak) such that inflation of LA balloon 102 coincides with atrialsystole (e.g., with the active contraction portion of the atrialpressure/volume cycle when the a wave peak occurs) at the end ofventricular diastole just before the mitral valve closes to enhance theatrial ventricular pressure differential and increase ventricularfilling (e.g., LV End Diastolic Volume, LVEDV).

FIG. 4 shows two LA pressure waveforms 300, 312 against the timing of anECG signal. The figure also indicates certain points of the cardiaccycle. For example, the LA contracting 302, the mitral valve closing304, the LA relaxing and filling 306, the LA is full 308, and the LAemptying 310. The unmodified waveform 312 shows a Left atrial pressurewaveform for a heart without the use of a LA balloon and modifiedwaveform 300 shows a Left atrial pressure waveform for a heart with theuse of a LA balloon. As shown, the a-wave peak (302 equivalent) of themodified waveform 300 is higher than 302 in the unmodified waveform 312when the LA contracts due to the inflation of the balloon, this waveboost amplifies the natural contractility of the Left Atrium which maybe diminished as a result of atrial dysfunction related to heart failureand/or atrial fibrillation and serves to improve left ventricularfilling and support cardiac output. Conversely, the deflation of theballoon just after the R peak causes a lower pressure during the fillingof the atrium (306 equivalent) and a lower v-wave peak (308 equivalent)as compared to the unmodified waveform 312. This reduction in fillingpressure should result in a decrease in pulmonary capillary wedgepressure and pulmonary congestion.

FIGS. 5-9 show exemplary implementations of LA balloon 102 and atrialpositioning structure 106.

In general, balloon 102 can be separate from its associated positioningstructure or can be incorporated with a positioning structure. In eitherimplementation, a positioning structure is provided that maintains theposition of its associated balloon within the heart throughout thecardiac cycle. In the example perspective views of FIG. 5, LA balloon102 is a dome-shaped expandable structure that is attached to atrialpositioning structure 106 configured to be positioned trans-septallywith a portion 700 that extends through the atrial septum. Portion 700can also be considered an atrial positioning structure, and may comprisea catheter body as described above that is temporarily positioned withinthe heart or a shorter trans-septal shaft that may be positioned in theheart over a longer term. The atrial positioning structure 106 comprisesa toroidal structure comprising an expandable wire mesh (for example,self-expanding, shape-set nitinol wire mesh) that may substantially takethe form of two discs 800 and 802, shown more particularly in FIG. 6.The system may be deployed from within a sheath that can constrain thediameter of the positioning structure 106 and the dome-shaped expandablestructure 102 as it is delivered trans-septally. Once the distal end hasbeen advanced into the Left Atrium, the sheath may be retracted (or theballoon catheter and positioning structure may be advanced relative tothe sheath) such that the distal disc with the balloon 102 attached isable to expand within the Left Atrium. The system may then be pulledback towards the Right Atrium to seat the proximal surface of the distaldisc against the left atrial facing surface of the septal wall. As thesheath retraction continues, the proximal disc is exposed and expandedsuch that the distal facing surface of the proximal disc seats againstthe right atrial facing surface of the septal wall to secure the systemrelative to the septum. The arrows in FIG. 5 illustrate how balloon 102can be alternatingly inflated and deflated.

FIG. 6 shows a partial cross-sectional side view of the atrialpositioning structure 106 and LA balloon 102 of FIG. 5, anchored withexpandable members 800 and 802 on either side of the atrial septum 809with balloon 102 incorporated into the LA side of the positioningstructure 106. Expandable member 800 and 802 can be collapsed forinsertion into the patient's heart (and through the atrial septum formember 802) and then expanded to secure positioning structure 106 to theseptum. The balloon 102 can comprise anti-thrombotic material. Thearrows in FIG. 6 illustrate how balloon 102, once anchored to the septum809, can be alternatingly inflated and deflated. Although a dome-shapedballoon 106 is shown in FIGS. 6 and 7, it should be appreciated that LAballoon 102 can be shaped as a toroidal loop or other form that allowsfor trans-septal access to the LA through a central lumen through theballoon 102. The central lumen providing a conduit to the Left Atriumcan be used as a guidewire lumen to facilitate initial delivery, directpressure measurement from a hub on the external portion of the catheter,a pressure sensor (e.g. a fiber optic pressure sensor), a shunt path tothe venous system, or any other purpose where access to the Left Atriummay be desired. For example, FIGS. 7A-7B shows an implementation of LAballoon 102 that comprises a multi-lumen catheter 902 that includes anopen central lumen 900 for maintaining access to the left atrialchamber. The catheter 902 includes another lumen 904 that can be used toinflate and deflate the balloon 102. A cross-sectional view of FIG. 7Ais shown in FIG. 7B. As shown, the central lumen 900 provide access tothe left atrial chamber as shown by the double-headed arrow 901.Additionally, the fluid lumen 904 can deliver fluid to and from theballoon 102 as depicted by the second double-headed arrow. 903.

In some operational scenarios, after temporarily treating the patientfor HF, a trans-septal LA balloon and atrial anchoring structure can beremoved and the trans-septal opening can be closed or left open. FIG. 8shows LA balloon 102 positioned in the LA by LA positioning structure106 implemented as a trans-septal anchor having first and second anchormembers 800 and 802 respectively disposed in the right and left atriaand LA balloon 102 attached to left-side member 802. FIG. 9 shows analternate implementation in which LA balloon 102 is anchored with astructure 106 that anchors at a distal end in the left atrial appendage(LAA). Anchoring in the LAA (e.g., with an expandable cage as shown inFIG. 9) can also be implemented such that that structure 106simultaneously closes off a portion of the LAA in order to help reduceoverall LA volume and minimize the risk of embolism and/or the effectsof AF. It should also be appreciated that LA anchoring structure 106 canbe anchored in other locations to position LA balloon 102 in the LA. Inone example, LA anchoring structure 106 may be an anchoring memberconfigured for anchoring in an orifice of one or more pulmonary veins.Additionally, in any of the embodiments described herein, and asindicated in FIGS. 8-9, feed line 110 can access the LA from thesuperior vena cava (SVC), as illustrated by the dotted line 114, or theinferior vena cava (IVC), as illustrated by the solid line 110, via theright atrium.

Another implementation of the LA balloon is shown in FIGS. 10A-10D. Thedistal end 504 of the LA balloon 502 is recessed within the LA balloon502. The invaginated tip allows for the distal end 504 of the balloon502 to be atraumatic, including but not limited to instances when aguidewire is not present. The balloon 502 can be anchored to the heartby similar anchoring mechanisms as described above, as shown in FIG.10D, but it does not require it, as shown in FIG. 10C. FIG. 10Cillustrates that the LA balloon 502 can be positioned within the LAusing a shaft 506 as the atrial positioning structure. In oneimplementation, the shaft 506 may be a multi-lumen polymer shaft. Theshaft 506 can be pre-formed with a bend or curve of approximately 60degrees or a variety of different angles to help facilitate properplacement during delivery and stabilization during activation. The shaft506 can comprise a plurality of lumens. For example, the shaft 506 canhave a separate lumen for a guidewire, a separate flow lumen to inflateand deflate the balloon 502, and a separate lumen for a fiber opticpressure sensor. The shaft 506 may also contain a lumen for housing astiffening stylet for stabilizing the distal tip of the catheter andmaintaining balloon position during activation. The stiffening styletcan be inserted before or after the distal tip has been advanced to itsdesired location. The stiffening stylet may be pre-formed with a bend orcurve to impart a desired bend or curve to the shaft 506.

In various implementations, LA balloon 102, 502 can have a shape that isspherical, oval, cylindrical, flat, dome-shaped, toroidal, or any othergeometric configuration suitable for pressurizing (e.g., increasing ordecreasing pressure in a controllable manner) the LA. The differentshapes can improve placement in the patient. In other implementations,the LA balloon 102, 502 can have different sizes to better suit theheart of a patient and/or provide preferential flow patterns uponinflation and/or deflation.

It should also be appreciated that an LA balloon such as LA balloon 102can be provided in conjunction with one or more other implantableelements.

FIG. 11 shows various components that may be incorporated into system100 described above that are not visible in FIG. 2 and that areconfigured to operate LA balloon 102 as described herein. FIG. 11illustrates components that may be usable in a single balloon system, asdescribed above, or in a dual balloon system, as described furtherbelow. Therefore, not all of the components illustrated in FIG. 11 maybe needed or utilized for a single balloon system. Further detailsregarding components of the system 100 are also described in U.S.Provisional Application No. 62/801,819, filed Feb. 6, 2019, includingbut not limited to FIG. 14 and paragraph [0046], the entirety of whichis hereby incorporated by reference. In the example of FIG. 11, system100 may include control circuitry (not shown), a power source (notshown), a pressure chamber or reservoir 1900, a vacuum chamber orreservoir 1902, and a pump 1907. As shown, solenoids 1908 may bedisposed on tubing that fluidly couples pressure chamber 1900 and vacuumchamber 1902 to a fluid line (e.g., implementations of fluid line 110 ofFIG. 2) can be controlled by control circuitry at microcontroller 1927to control the inflation and deflations of balloon 102. In oneembodiment, ECG sensors 1903 are connected to the patient 1901 and thepatient's ECG signal is sent to the data acquisition unit 1905, which isprogrammed by the software 1915 to look for a set threshold value thatcorrelates to the R-wave in the ECG signal. Once the threshold isdetected, the data acquisition unit 1905 sends a pulse (e.g., squarewave) to microcontroller 1927. The software 1915 monitors themicrocontroller 1927 for the pulses sent by the data acquisition unit1905 and uses that information to continuously calculate the intervalbetween R-waves (the R-R interval) of the ECG signal. The LA ballooninflation is timed using the calculated R-R intervals and the parameters1919 (including length of inflation time, offset/delay time afterdetection of ECG feature 1917, and fill volume), which may be adjustedwith the user input/controller 1921. Based on the R-R interval timingand the user input 1921, the software 1915 then communicates with themicrocontroller 1927 to actuate the solenoids 1908, opening the balloonlumen(s) to either the pressure chamber 1900 for inflation, or thevacuum chamber 1902 for deflation.

Although system 100 is depicted as an external fixed system (e.g., forbedside support), the components of FIG. 11 and the other figuresdescribed above can also be arranged for ambulatory use, or forimplantation in the patient (e.g., the drive system for balloon 102 canbe in an external console, a wearable external portable unit, or couldbe fully implantable). System 100 can be provided for temporary,short-term, mid-term, long-term, or permanent use. In temporary cases,LA positioning structure 106 is arranged to be removed from the patientatraumatically.

If desired, balloon 102 can be provided with a pressure sensor/monitor1923 that collects pressure data within the corresponding cavity, forexample a fiber optic pressure sensor or other similar method. Pressuredata from this pressure sensor can be used to drive or trigger theballoon inflation and/or deflation and/or can be collected to provideinformation to the patient, physician, or others in real-time via anoutput display 1925 or when uploaded separately. In some embodiments,sensors 1923 may also be used to monitor pressure inside the balloon forvarious purposes.

Although various examples are discussed herein in which LA pressurizingelement 102 is implemented as a balloon, it should be appreciated thatLA support system 100 can be implemented with other pressurizingelements such as active pumps, axial flow pumps, turbines, or othermechanisms for displacing volume and fluids. More generally, element 102can be implemented as any suitable combination of pressurizing (e.g.,pressure-control), fluid-displacement, and/or volume-displacementmechanisms that are biocompatible and implantable for positioning influid communication with one or more portions of the left side of apatient's heart. For example, LA pressurizing element 102, whenoperated, may cause a volume displacement in the Left Atrium.

FIG. 12 conceptually illustrates an electronic system with which one ormore aspects of the subject technology may be implemented. Electronicsystem, for example, may be, or may be a part of, control circuitry 1913for a left atrial support system implemented in standalone device, aportable electronic device such as a laptop computer, a tablet computer,a phone, a wearable device, or a personal digital assistant (PDA), orgenerally any electronic device that can be communicatively coupled topressurizing devices implanted in a patient's heart and or pulmonaryvasculature. Such an electronic system includes various types ofcomputer readable media and interfaces for various other types ofcomputer readable media. Electronic system includes bus 1008, processingunit(s) 1012, system memory 1004, read-only memory (ROM) 1010, permanentstorage device 1002, input device interface 1014, output deviceinterface 1006, and network interface 1016, or subsets and variationsthereof.

Bus 1008 collectively represents all system, peripheral, and chipsetbuses that communicatively connect the numerous internal devices ofelectronic system. In one or more embodiments, bus 1008 communicativelyconnects processing unit(s) 1012 with ROM 1010, system memory 1004, andpermanent storage device 1002. From these various memory units,processing unit(s) 1012 retrieves instructions to execute and data toprocess in order to execute the processes of the subject disclosure. Theprocessing unit(s) can be a single processor or a multi-core processorin different embodiments.

ROM 1010 stores static data and instructions that are needed byprocessing unit(s) 1012 and other modules of the electronic system.Permanent storage device 1002, on the other hand, is a read-and-writememory device. This device is a non-volatile memory unit that storesinstructions and data even when electronic system is off. One or moreembodiments of the subject disclosure use a mass-storage device (such asa magnetic or optical disk and its corresponding disk drive) aspermanent storage device 1002.

Other embodiments use a removable storage device (such as a floppy disk,flash drive, and its corresponding disk drive) as permanent storagedevice 1002. Like permanent storage device 1002, system memory 1004 is aread-and-write memory device. However, unlike storage device 1002,system memory 1004 is a volatile read-and-write memory, such as randomaccess memory. System memory 1004 stores any of the instructions anddata that processing unit(s) 1012 needs at runtime. In one or moreembodiments, the processes of the subject disclosure are stored insystem memory 1004, permanent storage device 1002, and/or ROM 1010. Fromthese various memory units, processing unit(s) 1012 retrievesinstructions to execute and data to process in order to execute theprocesses of one or more embodiments.

Bus 1008 also connects to input and output device interfaces 1014 and1006. Input device interface 1014 enables a user to communicateinformation and select commands to the electronic system and/or a sensorto communicate sensor data to processor 1012. Input devices used withinput device interface 1014 include, for example, alphanumerickeyboards, pointing devices (also called “cursor control devices”),cameras or other imaging sensors, electro-cardio sensors, pressuresensors, or generally any device that can receive input. Output deviceinterface 1006 enables, for example, the display of images generated byelectronic system. Output devices used with output device interface 1006include, for example, printers and display devices, such as a liquidcrystal display (LCD), a light emitting diode (LED) display, an organiclight emitting diode (OLED) display, a flexible display, a flat paneldisplay, a solid state display, a projector, or any other device foroutputting information. One or more embodiments may include devices thatfunction as both input and output devices, such as a touch screen. Inthese embodiments, feedback provided to the user can be any form ofsensory feedback, such as visual feedback, auditory feedback, or tactilefeedback; and input from the user can be received in any form, includingacoustic, speech, or tactile input. Output device interface 1006 mayalso be used to output control commands for operating pressurizingcomponents (e.g., to control pressurizing element 102) as describedherein.

Finally, as shown in FIG. 12, bus 1008 also couples electronic system toa network (not shown) through network interface 1016. In this manner,the computer can be a part of a network of computers (such as a localarea network (“LAN”), a wide area network (“WAN”), or an Intranet, or anetwork of networks, such as the Internet. Any or all components ofelectronic system can be used in conjunction with the subjectdisclosure.

Dual Cardiac Support System

FIGS. 13A-13B illustrate another example system 600 in which twoimplantable pressurizing elements have been implanted in the patient. Inthe example of FIGS. 13A-13B, system 600 includes a first pressurizingelement 102 implemented as a balloon for illustrative purposes. Asshown, an atrial positioning structure 106 is coupled to the firstpressurizing element 102 and configured to position the firstpressurizing element 102 in a Left Atrium LA of a heart 101 of apatient. Any of the atrial positioning structures described above may beutilized in the system 600 as described herein. As shown, system 600also includes a second pressurizing element 104 and a pulmonary arterypositioning structure 108 coupled to the second pressurizing element 104and configured to position the second pressurizing element 104 in aPulmonary Artery PA of the patient. Although not visible in FIGS.13A-13B, system 600 also includes control circuitry configured tooperate the first and second pressurizing elements 102, 104 to generatecoordinated pressure modifications and/or volume displacements in theLeft Atrium and the Pulmonary Artery. Feed lines 110 and 112 are shown,through which a fluid or a gas can be provided or removed for inflationor deflation of balloon implementations of pressurizing elements 102 and104, or with which control signals can be provided for operation ofother implementations of pressurizing elements 102 and 104. As describedabove, the feed line 110 may be incorporated into or be part of anelongate catheter body used to deliver the pressurizing element 102 tothe Left Atrium LA. The feed line 112 may be incorporated into or bepart of an elongate catheter used to deliver the pressurizing element104 and the pulmonary artery positioning structure 108 to the right sideof the heart. For example, in both balloon and non-balloon embodiments,in some aspects a catheter or sheath may be delivered in a percutaneousapproach through the femoral vein and advanced through the inferior venacava, to the Right Atrium RA, to the Right Ventricle RV, and into thePulmonary Artery PA. The pressurizing element 104 is positioned at ornear a distal end of the elongate body and may be expanded in the PA. Anexpandable pulmonary artery positioning structure 108, shown distal tothe balloon in FIGS. 13A and 13B, may expand in the Pulmonary Artery (orelsewhere) to help secure the balloon within the PA. In someembodiments, the pulmonary artery positioning structure 108 comprises anexpandable cage that may be secured at the bifurcation of the PA.

System 600 may also include one or more sensors such aselectrocardiogram (ECG) sensors and/or pressure sensors that generatesignals that correspond to portions of the cardiac cycle of the patient.Pressurizing elements 102 and 104 can be operated to generatecoordinated pressure changes (e.g., pressure increases and/or pressuredecreases) in the Left Atrium and Pulmonary Artery respectively, incoordination with various portions of the cardiac cycle based on thesignals from the sensor.

In accordance with aspects of the present disclosure, the dual-sidedsystem 600 of FIGS. 13A-13B is provided to address potential dysfunctionon both sides of the heart. In contrast with HFpEF treatments withdevices that merely reduce LA pressure only at the cost of increasingthe burden on the right side of the heart and reducing cardiac output,system 600 as described herein supports the heart by unloading theburden on both side of the lungs, thereby reducing congestion andpulmonary wedge pressure and improving LV diastolic filling to supportcardiac output. This is achieved by placing one fluid/volume displacingsystem on the left side of the heart (e.g., pressurizing element 102 inthe Left Atrium) and another fluid/volume displacing system on the rightside of the heart (e.g., pressurizing element 104 in the PulmonaryArtery). In the example discussed herein in which pressurizing element102 and pressurizing element 104 are implemented as balloons, thecoordinated inflation (see FIG. 13A) and deflation of the balloons (seeFIG. 13B) is timed in such a way to optimize support for each patientand keep blood moving in the proper direction at all times during thecardiac cycle. FIG. 13A illustrates when the balloons 102, 104 areinflated and FIG. 13B illustrates when the balloons 102, 104 aredeflated.

On the right side, deflation of the balloon can serve to reduce theafterload and work required of the Right Ventricle and improve fillingefficiency in the lungs during inflation, as shown in FIG. 13B. Forexample, actively deflating the PA balloon 104 during PA systole willreduce PA systolic pressures and RV work load. Then subsequentlyinflating the PA balloon 104, as shown in FIG. 13A, during PA diastoleafter the pulmonary valve is closed will increase PA diastolic pressureand help overcome pulmonary vascular resistance to provide greatercardiac output. On the left side, deflation of a balloon 102 in the LeftAtrium during atrial diastole can help draw oxygenated blood out of thelungs by simulating an increase in LA reservoir strain (e.g., increasein volume during filling) increasing the relative volume of the LA andreducing the filling pressures. Then, by inflating balloon 102 duringthe active portion of the diastolic cycle (e.g., during atrial systole)the balloon can simulate an increase in LA pump/active strain byreducing the relative volume in the LA and increasing LA pressure duringthe active phase of the cycle, thereby increasing the LA-to-LV pressuredifferential and improving diastolic filling of the Left Ventricle. Thiscoordinated operation of LA balloon 102 and PA balloon 104 serves torestore compliance to areas of the heart (e.g., the LA and PA) that areexperiencing increased stiffness and wall stress.

In various operational scenarios, balloons 102 and 104 (or otherimplementations of the pressurizing elements for fluid/volumedisplacement in the LA and PA) can be operated independently or inconcert (e.g., with direct synchronicity, exact opposite functionality,or an overlapping sequence with different delays in timing of inflationand deflation throughout the cardiac cycle), depending on the placementof the balloons and the specific needs of each patient.

Inflation and deflation of balloons 102 and 104 can be based on aninitial (e.g., fixed) timing or can be triggered by sensor signals fromelectrocardiogram (e.g., EKG or ECG) sensors, pressure sensors (e.g., apressure sensor in or near the LA and a pressure sensor in our near thePA), or a combination thereof.

As described above, FIG. 3 shows a waveform 202 illustrating a potentialsequence of balloon inflations and deflations for the LA balloon 102against the timing of an ECG signal 200. FIG. 3 also shows a waveform204 illustrating a potential sequence of balloon inflations anddeflations for the PA balloon 104.

In one exemplary implementation of the timing for balloons 102 and 104that can generate the waveforms of FIG. 3, the PA balloon 104 istriggered to deflate upon detection of the R peak in the ECG signal andinflate upon detection of the T peak in the ECG signal (or a specifictiming offset from the R peak that coincides with the T wave) so thatthe deflation and inflation coincide with the opening and closing of thepulmonary valve, respectively—and the beginning of systole and diastolerespectively. In this example, the LA balloon 102 is triggered todeflate upon detection of the R peak plus a time delay (e.g., a 100millisecond delay after the R peak). In this way, the system initiatesdeflation of LA balloon 102 right after initiating the deflation of thePA balloon 104 such that deflation of the LA balloon 102 coincides withthe natural expansion/reservoir function phase of the LA pressure/volumecycle which occurs during ventricular systole when the mitral valve isclosed. LA balloon 102 inflation can be triggered to initiate based ondetection of the peak of the P wave of the ECG or the R peak plus anadditional time delay (e.g., a 600 millisecond time delay after the Rpeak) such that inflation of LA balloon 102 coincides with atrialsystole (e.g., with the active contraction portion of the atrialpressure/volume cycle when the a-wave peak occurs) at the end ofventricular diastole just before the mitral valve closes to enhance theatrial ventricular pressure differential and increase ventricularfilling (e.g., LV End Diastolic Volume, LVEDV).

FIG. 7 of U.S. Provisional Application No. 62/801,917, filed Feb. 6,2019, the entirety of which is incorporated by reference herein, shows aseries of wave forms that indicate Aortic, PA, Atrial, and Ventricularpressure over the course of two cardiac cycles, against the timing of anECG signal 1604. In addition, a waveform 1600 illustrating a potentialsequence of balloon inflations and deflations for the LA balloon 102 anda waveform 1602 illustrating a potential sequence of balloon inflationsand deflations for PA balloon 104 are also shown. In addition, theresulting impact of the balloon inflations of waveforms 1600 and 1602 onthe LA and PA pressure waves are illustrated in augmented LA pressurewaveform 1606 and augmented PA pressure waveform 1608.

As illustrated in FIGS. 14-17, for PA balloon 104, the PA positioningstructure 108 can be distal to the balloon 104 and can be implemented asan expandable cage that anchors against the walls of the PA afterexpansion from an elongated configuration as shown in FIG. 14 (e.g., forpassing through the vascular system to the PA) through an intermediatelyexpanded configuration as shown in FIG. 15, to a fully expandedconfiguration as shown in FIG. 16 (e.g., rotating a coupled torque shaftcounterclockwise could extend the proximal portion from the distalportion along an internal thread and compress the anchoring structure,while rotating the torque shaft clockwise could bring the distal andproximal ends of the anchoring structure closer together and expand itsdiameter). FIG. 16 also shows PA balloon 104 in an inflatedconfiguration. Also shown in FIGS. 14-16 is a guidewire 120 that can beindependently inserted and advanced into the desired location within theanatomy (in this case the PA) before the balloon catheter and anchoringsystem are introduced, such that the balloon catheter and anchoringsystem can be tracked into position over the guidewire. The guidewirecan then be removed or left in place during the course of treatment.

Although FIGS. 14-17 show PA positioning structure 108 distally disposedrelative to PA balloon 104, it should be appreciated that PA positioningstructure 108 can be disposed proximal to PA balloon 104 or incorporatedin-line with the balloon (e.g., as a cage around the balloon). Asindicated in FIG. 16, PA positioning structure 108 allows blood flowtherethrough.

FIG. 17 shows PA balloon 104 positioned within the PA by PA positioningstructure 108 implemented as an expanded cage at the top of the PA. Asindicated in FIG. 17, feed line 112 can access the PA from the SVC orinferior IVC, as illustrated by the solid line 112, via the right atriumand right ventricle.

In various implementations, LA balloon 102 and PA balloon 104 can havethe same shape or different shapes, with the shape of either balloonbeing spherical, oval, cylindrical, flat, dome-shaped, toroidal, or anyother geometric configuration suitable for pressurizing (e.g.,increasing or decreasing pressure in a controllable manner) the LAand/or the PA.

Although HFpEF treatments using a system 100 having a LA pressurizingelement 102 and a PA pressurizing element 104 are described herein,other systems for treatment of HFpEF and/or AF are contemplated hereinthat address the dual-sided problem in accordance with the cardiac cyclefeatures discussed in connection with FIG. 2. As another example, FIG.18 illustrates a balloon 1702A that is shaped as a spiral to enhanceforward flow boost. The balloon 1702A may be configured for positioningin the PA as described above. In other embodiments, any of the balloonsor pressurizing elements as described herein in the PA may be configuredfor positioning in the Right Ventricle RV.

FIG. 11 shows various components that may be incorporated into system600 described above that are not visible in FIGS. 13A-13B and that areconfigured to operate LA balloon 102 and PA balloon 104 as describedherein. Further details regarding components of the system 100 are alsodescribed in U.S. Provisional Application No. 62/801,917, filed Feb. 6,2019, including but not limited to FIG. 21 and paragraph [0057], theentirety of which is hereby incorporated by reference. In the example ofFIG. 11, system 600 may include control circuitry (not shown), a powersource (not shown), a pressure chamber or reservoir 1900, a vacuumchamber or reservoir 1902, and a pump 1907. As shown, solenoids 1908,1909 may be disposed on tubing that fluidly couples pressure chamber1900 and vacuum chamber 1902 to fluid lines (e.g., implementations offluid lines 110 and 112 of FIGS. 13A-13B) can be controlled by controlcircuitry at microprocessor 1927 to control the inflation and deflationsof balloons 102 and 104. In one embodiment, ECG sensors 1903 areconnected to the patient 1901 and the patient's ECG signal is sent tothe data acquisition unit 1905 (Power Lab), which is programmed to lookfor a set threshold value that correlates to the R-wave in the ECGsignal. Once the threshold is detected, the data acquisition unit 1905sends a pulse (square wave) to a microcontroller 1927. The software 1915monitors the microcontroller 1927 for the pulses sent by the dataacquisition unit 1905 and uses that information to continuouslycalculate the interval between R-waves (the R-R interval) of the ECGsignal. The PA and LA balloon inflation is timed using the calculatedR-R intervals and the parameters 1919, 1929 (including length ofinflation time, offset/delay time after detection of ECG feature 1917,and fill volume), which are adjusted with the user input/controller1921. Based on the R-R interval timing and the user input 1921, thesoftware then communicates with the microcontroller 1927 to actuate thesolenoids 1908, 1909, opening the balloon lumen(s) to either thepressure chamber 1900 for inflation, or the vacuum chamber 1902 fordeflation.

Although system 600 is depicted as an external fixed system (e.g., forbedside support), the components of FIG. 11 and the other figuresdescribed above can also be arranged for ambulatory use, or forimplantation in the patient (e.g., the drive system for balloons 102 and104 can be in an external console, a wearable external portable unit, orcould be fully implantable). System 600 can provided for temporary,short-term, mid-term, long-term, or permanent use. In temporary cases,LA and PA positioning structures 106 and 108 are arranged to be removedfrom the patient atraumatically.

If desired, balloons 102 and/or 104 can be provided with a pressuresensor/monitor 1923, 1931 that collect pressure data within thecorresponding cavity. Pressure data from these pressure sensors can beused to drive or trigger the balloon inflation and/or deflation and/orcan be collected to provide information to the patient, physician, orothers in real-time via an output display 1925 or when uploadedseparately. In some embodiments, sensors 1923, 1931 may also be used tomonitor pressure inside the balloons for various purposes.

Although various examples are discussed herein in which LA pressurizingelement 102 and PA pressurizing element 104 are implemented as balloons,it should be appreciated that dual-sided system 600 can be implementedwith other pressurizing elements such as active pumps, axial flow pumps,turbines, or other mechanisms for displacing volume and fluids. Moregenerally, each of elements 102 and 104 can be implemented as anysuitable combination of pressure-control, fluid-displacement, and/orvolume-displacement mechanisms that are biocompatible and implantablefor positioning in fluid communication with one or more portions of theleft or right side of a patient's heart. For example, LA pressurizingelement 102, when operated, may cause a volume displacement in the LeftAtrium, and PA pressurizing element 104, when operated, may cause avolume displacement in the Pulmonary Artery. As would be understood byone of ordinary skill in the art, the left side of the heart includesthe Left Atrium and the Left Ventricle, and receives oxygen-rich bloodfrom the lungs and pumps the oxygen-rich blood to the body. As would beunderstood by one of ordinary skill in the art, the right side of theheart includes the right atrium and the right ventricle, and receivesblood from the body and pumps the blood to the lungs for oxygenation.

Similar to the single balloon system described above, FIG. 12conceptually illustrates an electronic system with which one or moreaspects of the subject technology may be implemented. Electronic system,for example, may be, or may be a part of, control circuitry 1913 for adual-sided cardio-pulmonary support system implemented in standalonedevice, a portable electronic device such as a laptop computer, a tabletcomputer, a phone, a wearable device, or a personal digital assistant(PDA), or generally any electronic device that can be communicativelycoupled to pressurizing devices implanted in a patient's heart and orpulmonary vasculature. Such an electronic system includes various typesof computer readable media and interfaces for various other types ofcomputer readable media. Electronic system includes bus 1008, processingunit(s) 1012, system memory 1004, read-only memory (ROM) 1010, permanentstorage device 1002, input device interface 1014, output deviceinterface 1006, and network interface 1016, or subsets and variationsthereof.

Bus 1008 collectively represents all system, peripheral, and chipsetbuses that communicatively connect the numerous internal devices ofelectronic system. In one or more embodiments, bus 1008 communicativelyconnects processing unit(s) 1012 with ROM 1010, system memory 1004, andpermanent storage device 1002. From these various memory units,processing unit(s) 1012 retrieves instructions to execute and data toprocess in order to execute the processes of the subject disclosure. Theprocessing unit(s) can be a single processor or a multi-core processorin different embodiments.

ROM 1010 stores static data and instructions that are needed byprocessing unit(s) 1012 and other modules of the electronic system.Permanent storage device 1002, on the other hand, is a read-and-writememory device. This device is a non-volatile memory unit that storesinstructions and data even when electronic system is off. One or moreembodiments of the subject disclosure use a mass-storage device (such asa magnetic or optical disk and its corresponding disk drive) aspermanent storage device 1002).

Other embodiments use a removable storage device (such as a floppy disk,flash drive, and its corresponding disk drive) as permanent storagedevice 1002. Like permanent storage device 1002, system memory 1004 is aread-and-write memory device. However, unlike storage device 1002,system memory 1004 is a volatile read-and-write memory, such as randomaccess memory. System memory 1004 stores any of the instructions anddata that processing unit(s) 1012 needs at runtime. In one or moreembodiments, the processes of the subject disclosure are stored insystem memory 1004, permanent storage device 1002, and/or ROM 1010. Fromthese various memory units, processing unit(s) 1012 retrievesinstructions to execute and data to process in order to execute theprocesses of one or more embodiments.

Bus 1008 also connects to input and output device interfaces 1014 and1006. Input device interface 1014 enables a user to communicateinformation and select commands to the electronic system and/or a sensorto communicate sensor data to processor 1012. Input devices used withinput device interface 1014 include, for example, alphanumerickeyboards, pointing devices (also called “cursor control devices”),cameras or other imaging sensors, electro-cardio sensors, pressuresensors, or generally any device that can receive input. Output deviceinterface 1006 enables, for example, the display of images generated byelectronic system. Output devices used with output device interface 1006include, for example, printers and display devices, such as a liquidcrystal display (LCD), a light emitting diode (LED) display, an organiclight emitting diode (OLED) display, a flexible display, a flat paneldisplay, a solid state display, a projector, or any other device foroutputting information. One or more embodiments may include devices thatfunction as both input and output devices, such as a touch screen. Inthese embodiments, feedback provided to the user can be any form ofsensory feedback, such as visual feedback, auditory feedback, or tactilefeedback; and input from the user can be received in any form, includingacoustic, speech, or tactile input. Output device interface 1006 mayalso be used to output control commands for operating pressurizingcomponents (e.g., to control pressurizing elements 102 and 104) asdescribed herein.

Finally, as shown in FIG. 12, bus 1008 also couples electronic system toa network (not shown) through network interface 1016. In this manner,the computer can be a part of a network of computers (such as a localarea network (“LAN”), a wide area network (“WAN”), or an Intranet, or anetwork of networks, such as the Internet. Any or all components ofelectronic system can be used in conjunction with the subjectdisclosure.

Other Variations and Terminology

Many of the above-described features and applications may be implementedas software processes that are specified as a set of instructionsrecorded on a computer readable storage medium (alternatively referredto as computer-readable media, machine-readable media, ormachine-readable storage media). When these instructions are executed byone or more processing unit(s) (e.g., one or more processors, cores ofprocessors, or other processing units), they cause the processingunit(s) to perform the actions indicated in the instructions. Examplesof computer readable media include, but are not limited to, RAM, ROM,read-only compact discs (CD-ROM), recordable compact discs (CD-R),rewritable compact discs (CD-RW), read-only digital versatile discs(e.g., DVD-ROM, dual-layer DVD-ROM), a variety of recordable/rewritableDVDs (e.g., DVD-RAM, DVD-RW, DVD+RW, etc.), flash memory (e.g., SDcards, mini-SD cards, micro-SD cards, etc.), magnetic and/or solid statehard drives, ultra-density optical discs, any other optical or magneticmedia, and floppy disks. In one or more embodiments, the computerreadable media does not include carrier waves and electronic signalspassing wirelessly or over wired connections, or any other ephemeralsignals. For example, the computer readable media may be entirelyrestricted to tangible, physical objects that store information in aform that is readable by a computer. In one or more embodiments, thecomputer readable media is non-transitory computer readable media,computer readable storage media, or non-transitory computer readablestorage media.

In one or more embodiments, a computer program product (also known as aprogram, software, software application, script, or code) can be writtenin any form of programming language, including compiled or interpretedlanguages, declarative or procedural languages, and it can be deployedin any form, including as a standalone program or as a module,component, subroutine, object, or other unit suitable for use in acomputing environment. A computer program may, but need not, correspondto a file in a file system. A program can be stored in a portion of afile that holds other programs or data (e.g., one or more scripts storedin a markup language document), in a single file dedicated to theprogram in question, or in multiple coordinated files (e.g., files thatstore one or more modules, sub programs, or portions of code). Acomputer program can be deployed to be executed on one computer or onmultiple computers that are located at one site or distributed acrossmultiple sites and interconnected by a communication network.

While the above discussion primarily refers to microprocessor ormulti-core processors that execute software, one or more embodiments areperformed by one or more integrated circuits, such as applicationspecific integrated circuits (ASICs) or field programmable gate arrays(FPGAs). In one or more embodiments, such integrated circuits executeinstructions that are stored on the circuit itself.

Those of skill in the art would appreciate that the various illustrativeblocks, modules, elements, components, methods, and algorithms describedherein may be implemented as electronic hardware, computer software, orcombinations of both. To illustrate this interchangeability of hardwareand software, various illustrative blocks, modules, elements,components, methods, and algorithms have been described above generallyin terms of their functionality. Whether such functionality isimplemented as hardware or software depends upon the particularapplication and design constraints imposed on the overall system.Skilled artisans may implement the described functionality in varyingways for each particular application. Various components and blocks maybe arranged differently (e.g., arranged in a different order, orpartitioned in a different way) all without departing from the scope ofthe subject technology.

It is understood that any specific order or hierarchy of blocks in theprocesses disclosed is an illustration of example approaches. Based uponimplementation preferences, it is understood that the specific order orhierarchy of blocks in the processes may be rearranged, or that not allillustrated blocks be performed. Any of the blocks may be performedsimultaneously. In one or more embodiments, multitasking and parallelprocessing may be advantageous. Moreover, the separation of varioussystem components in the embodiments described above should not beunderstood as requiring such separation in all embodiments, and itshould be understood that the described program components and systemscan generally be integrated together in a single software product orpackaged into multiple software products.

The subject technology is illustrated, for example, according to variousaspects described above. The present disclosure is provided to enableany person skilled in the art to practice the various aspects describedherein. The disclosure provides various examples of the subjecttechnology, and the subject technology is not limited to these examples.Various modifications to these aspects will be readily apparent to thoseskilled in the art, and the generic principles defined herein may beapplied to other aspects.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically so stated, but rather “one or more.”Unless specifically stated otherwise, the term “some” refers to one ormore. Pronouns in the masculine (e.g., his) include the feminine andneuter gender (e.g., her and its) and vice versa. Headings andsubheadings, if any, are used for convenience only and do not limit theinvention.

The word “exemplary” is used herein to mean “serving as an example orillustration.” Any aspect or design described herein as “exemplary” isnot necessarily to be construed as preferred or advantageous over otheraspects or designs. In one aspect, various alternative configurationsand operations described herein may be considered to be at leastequivalent.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “or” to separate any of the items, modifies thelist as a whole, rather than each item of the list. The phrase “at leastone of” does not require selection of at least one item; rather, thephrase allows a meaning that includes at least one of any one of theitems, and/or at least one of any combination of the items, and/or atleast one of each of the items. By way of example, the phrase “at leastone of A, B, or C” may refer to: only A, only B, or only C; or anycombination of A, B, and C.

A phrase such as an “aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations.An aspect may provide one or more examples. A phrase such as an aspectmay refer to one or more aspects and vice versa. A phrase such as an“embodiment” does not imply that such embodiment is essential to thesubject technology or that such embodiment applies to all configurationsof the subject technology. A disclosure relating to an embodiment mayapply to all embodiments, or one or more embodiments. An embodiment mayprovide one or more examples. A phrase such an embodiment may refer toone or more embodiments and vice versa. A phrase such as a“configuration” does not imply that such configuration is essential tothe subject technology or that such configuration applies to allconfigurations of the subject technology. A disclosure relating to aconfiguration may apply to all configurations, or one or moreconfigurations. A configuration may provide one or more examples. Aphrase such a configuration may refer to one or more configurations andvice versa.

In one aspect, unless otherwise stated, all measurements, values,ratings, positions, magnitudes, sizes, and other specifications that areset forth in this specification, including in the claims that follow,are approximate, not exact. In one aspect, they are intended to have areasonable range that is consistent with the functions to which theyrelate and with what is customary in the art to which they pertain.

It is understood that some or all steps, operations, or processes may beperformed automatically, without the intervention of a user. Methodclaims may be provided to present elements of the various steps,operations or processes in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

All structural and functional equivalents to the elements of the variousaspects described throughout this disclosure that are known or latercome to be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe appended claims. Moreover, nothing disclosed herein is intended tobe dedicated to the public regardless of whether such disclosure isexplicitly recited in the claims. No claims element is to be construedunder the provisions of 35 U.S.C. § 112 (f) unless the element isexpressly recited using the phrase “means for” or, in the case of amethod, the element is recited using the phrase “step for.” Furthermore,to the extent that the term “include,” “have,” or the like is used, suchterm is intended to be inclusive in a manner similar to the term“comprise” as “comprise” is interpreted when employed as a transitionalword in a claim.

The Title, Background, Brief Description of the Drawings, and Claims ofthe disclosure are hereby incorporated into the disclosure and areprovided as illustrative examples of the disclosure, not as restrictivedescriptions. It is submitted with the understanding that they will notbe used to limit the scope or meaning of the claims. In addition, in theDetailed Description, it can be seen that the description providesillustrative examples and the various features are grouped together invarious embodiments for the purpose of streamlining the disclosure. Thismethod of disclosure is not to be interpreted as reflecting an intentionthat the claimed subject matter requires more features than areexpressly recited in any claim. Rather, as the following claims sreflect, inventive subject matter lies in less than all features of asingle disclosed configuration or operation. The following claims arehereby incorporated into the Detailed Description, with each claimsstanding on its own to represent separately claimed subject matter.

The claims are not intended to be limited to the aspects describedherein, but are to be accorded the full scope consistent with thelanguage of the claims and to encompass all legal equivalents.Notwithstanding, none of the claims are intended to embrace subjectmatter that fails to satisfy the requirement of 35 U.S.C. § 101, 102, or103, nor should they be interpreted in such a way.

Various modifications to the implementations described in thisdisclosure may be readily apparent to those skilled in the art, and thegeneric principles defined herein may be applied to otherimplementations without departing from the spirit or scope of thisdisclosure. Thus, the disclosure is not intended to be limited to theimplementations shown herein, but is to be accorded the widest scopeconsistent with the principles and features disclosed herein. Certainembodiments of the disclosure are encompassed in the claim set listedbelow or presented in the future.

Certain embodiments of the disclosure are encompassed in the claimspresented at the end of this specification, or in other claims presentedat a later date. Additional embodiments are encompassed in the followingset of numbered embodiments:

Embodiment 1

A system, comprising:

-   -   a pressurizing element;    -   an atrial positioning structure coupled to the pressurizing        element and configured to position the pressurizing element in a        left atrium of a heart of a patient; and    -   control circuitry configured to:        -   operate the pressurizing element to decrease a pressure in            the left atrium during atrial diastole to draw oxygenated            blood out of the lungs of the patient by increasing left            atrial reservoir strain and a relative volume of the left            atrium to reduce a filling pressure in the left atrium; and        -   operate the pressurizing element to increase the pressure in            the left atrium during atrial systole to increase active            strain by reducing a relative volume of the left atrium to            increase a left atrial pressure during atrial systole,            wherein the increase in the left atrial pressure during            atrial systole increases a pressure differential between the            left atrium and left ventricle that improves diastolic            filling of the left ventricle.

Embodiment 2

The system of Embodiment 1, wherein the pressurizing element comprises aballoon, wherein operating the pressurizing element to increase thepressure in the left atrium comprises filling the balloon with a liquidor a gas, and wherein operating the pressurizing element to decrease thepressure in the left atrium comprises removing the liquid or the gasfrom the balloon.

Embodiment 3

The system of Embodiment 2, wherein the atrial positioning structurecomprises a septal anchor or a left atrial appendage anchor.

Embodiment 4

The system of Embodiment 3, further comprising pressurizing componentsthat include a pressure chamber and at least one pump disposed betweenthe balloon and the pressure chamber.

Embodiment 5

The system of Embodiment 4, wherein the pressurizing components areconfigured to be external fixed, external ambulatory, or implantablecomponents.

Embodiment 6

The system of Embodiment 3, wherein the atrial positioning structurecomprises the septal anchor, wherein the septal anchor comprises firstand second expandable members configured to expand respectively againstleft and right sides of an atrial septum of the heart of the patient,and wherein the balloon is attached to the first expandable member.

Embodiment 7

The system of Embodiment 6, wherein the pressurizing element comprises aturbine.

Embodiment 8

The system of Embodiment 1, wherein the pressurizing element comprises apump.

Embodiment 9

The system of Embodiment 1, wherein the pressurizing element, whenoperated, causes a volume displacement in the left atrium.

Embodiment 10

A method, comprising:

-   -   deflating a balloon disposed in a left atrium of a heart of a        patient to decrease a pressure in the left atrium during atrial        diastole to draw oxygenated blood out of the lungs of the        patient by increasing left atrial reservoir strain and a        relative volume of the left atrium to reduce a filling pressure        in the left atrium; and    -   inflating the balloon to increase the pressure in the left        atrium during atrial systole to increase active strain by        reducing a relative volume of the left atrium to increase a left        atrial pressure during atrial systole, wherein the increase in        the left atrial pressure during atrial systole increases a        pressure differential between the left atrium and left ventricle        that improves diastolic filling of the left ventricle.

Embodiment 11

The method of Embodiment 10, wherein deflating the balloon comprises:

-   -   receiving, at control circuitry from a sensor communicatively        coupled to the patient, a signal corresponding to a cardiac        cycle for the heart of the patient; and    -   deflating the balloon responsive to a portion of the signal.

Embodiment 12

The method of Embodiment 11, wherein inflating the balloon comprisesinflating the balloon responsive to an additional portion of the signal.

Embodiment 13

The method of Embodiment 12, wherein the sensor comprises an electricalsensor or a pressure sensor.

Embodiment 14

A system, comprising:

-   -   a first pressurizing element;    -   an atrial positioning structure coupled to the first        pressurizing element and configured to position the first        pressurizing element in a left atrium of a heart of a patient;    -   a second pressurizing element;    -   a pulmonary artery positioning structure coupled to the second        pressurizing element and configured to position the second        pressurizing element in a pulmonary artery of the patient; and    -   control circuitry configured to operate the first and second        pressurizing elements to generate coordinated pressure        modifications in the left atrium and the pulmonary artery.

Embodiment 15

The system of Embodiment 14, further comprising at least one sensorconfigured to sense a portion of a cardiac cycle for the patient, andwherein the control circuitry is configured to operate the first andsecond pressurizing elements to generate the coordinated pressuremodifications responsive to a signal from the sensor.

Embodiment 16

The system of Embodiment 15, wherein the coordinated pressuremodifications comprise a pressure change in the left atrium by operationof the first pressurizing element responsive to the signal and apressure change in the pulmonary artery by the second pressurizingelement based on the operation of the first pressurizing element.

Embodiment 17

The system of Embodiment 16, wherein the coordinated pressuremodifications comprise reversing the pressure change in the left atriumwith the first pressurizing element at a predetermined time after thepressure change by the first pressurizing element.

Embodiment 18

The system of Embodiment 16, wherein the coordinated pressuremodifications comprise reversing the pressure change in the left atriumwith the first pressurizing element responsive to an additional signalfrom the at least one sensor.

Embodiment 19

The system of Embodiment 15, wherein the coordinated pressuremodifications comprise causing a pressure change in the left atrium withthe first pressurizing element responsive to the signal and causing apressure change in the pulmonary artery with the second pressurizingelement responsive to an additional signal from the at least one sensor.

Embodiment 20

The system of Embodiment 19, wherein the coordinated pressuremodifications comprise reversing the pressure change in the left atriumwith the first pressurizing element at a predetermined time after thepressure change by the first pressurizing element.

Embodiment 21

The system of Embodiment 19, wherein the coordinated pressuremodifications comprise reversing the pressure change in the left atriumwith the first pressurizing element responsive to a further additionalsignal from the at least one sensor.

Embodiment 22

The system of Embodiment 15, wherein the coordinated pressuremodifications comprise, during the cardiac cycle with the firstpressurizing element, generating two pressure-increase periods separatedby a pressure-decrease period that is longer than either of the twopressure-increase periods.

Embodiment 23

The system of Embodiment 21, wherein the coordinated pressuremodifications comprise, during the cardiac cycle with the secondpressurizing element, generating a pressure-decrease period, and apressure-increase period that is longer than the pressure-decreaseperiod.

Embodiment 24

The system of Embodiment 21, wherein the pressure-decrease period forthe first pressurizing element and the pressure-increase period for thesecond pressurizing element are offset in time and extend for a commonamount of time.

Embodiment 25

The system of Embodiment 15, wherein the at least one sensor comprisesan electrical sensor configured to sense an electro-cardio signal in thepatient.

Embodiment 26

The system of Embodiment 15, wherein the at least one sensor comprisesat least one pressure sensor configured to sense a cardio-pulmonarypressure of the patient.

Embodiment 27

The system of Embodiment 26, wherein the at least one pressure sensorcomprises a first pressure sensor in or near the left atrium and asecond pressure sensor in or near the pulmonary artery.

Embodiment 28

The system of Embodiment 14, wherein the first pressurizing elementcomprises a first balloon and the second pressurizing element comprisesa second balloon.

Embodiment 29

The system of Embodiment 28, further comprising pressurizing componentsthat include a pressure chamber and at least one pump disposed betweenthe first and second balloons and the pressure chamber.

Embodiment 30

The system of Embodiment 29, wherein the control circuitry is configuredto operate the pressurizing components to generate the coordinatedpressure modifications with the first and second pressurizing elementsby:

-   -   triggering deflation of the second balloon responsive to        detection of an R peak in an electro-cardiogram signal for a        cardiac cycle for the patient;    -   triggering deflation of the first balloon following a first time        delay after the detection of the R peak;    -   triggering inflation of the second balloon responsive to        detection of a T peak in the electro-cardiogram signal for the        cardiac cycle for the patient; and    -   triggering inflation of the first balloon following a second        time delay after the R peak.

Embodiment 31

The system of Embodiment 30, wherein the first time delay is between 90milliseconds and 110 milliseconds, and wherein the second time delay isbetween 500 milliseconds and 700 milliseconds.

Embodiment 32

The system of Embodiment 30, wherein the deflation of the second balloonresponsive to the detection of the R peak coincides with an opening of apulmonary valve of the heart of the patient and a beginning of systole.

Embodiment 33

The system of Embodiment 32, wherein the inflation of the second balloonresponsive to the detection of the T peak coincides with a closing ofthe pulmonary valve of the heart of the patient and a beginning ofdiastole.

Embodiment 34

The system of Embodiment 33, wherein the deflation of the first ballooncoincides with a natural expansion and reservoir function phase of aleft atrial cycle which occurs during ventricular systole when a mitralvalve of the heart of the patient is closed.

Embodiment 35

The system of Embodiment 34, wherein the inflation of the first ballooncoincides with atrial systole at an end of ventricular diastole beforethe mitral valve closes.

Embodiment 36

The system of Embodiment 35, wherein the inflation of the first balloonincreases an atrial-ventricular pressure differential and increasesventricular filling for a left ventricle of the heart of the patient.

Embodiment 37

The system of Embodiment 29, wherein the control circuitry is configuredto operate the pressurizing components to generate coordinated pressuremodifications with the first and second pressurizing elements byoperating the pressurizing components to:

-   -   deflate the second balloon during pulmonary artery systole to        reduce pulmonary artery systolic pressures and reduce a work        load of a right ventricle of the heart of the patient;    -   inflate the second balloon during pulmonary artery diastole        after a pulmonary valve is closed to increase pulmonary artery        diastolic pressure to overcome pulmonary vascular resistance and        increase cardiac output;    -   deflate the first balloon during atrial diastole to draw        oxygenated blood out of the lungs of the patient by increasing        left atrial reservoir strain and a relative volume of the left        atrium to reduce a filling pressure in the left atrium; and    -   inflate the first balloon during atrial systole to increase        active strain by reducing a relative volume of the left atrium        to increase a left atrial pressure during atrial systole.

Embodiment 38

The system of Embodiment 37, wherein the increase in the left atrialpressure during atrial systole increases a pressure differential betweenthe left atrium and left ventricle that improves diastolic filling ofthe left ventricle.

Embodiment 39

The system of Embodiment 29, wherein the pressurizing components areconfigured to be external fixed, external ambulatory, or implantablecomponents.

Embodiment 40

The system of Embodiment 14, wherein the first pressurizing element orthe second pressurizing element comprises a turbine.

Embodiment 41

The system of Embodiment 14, wherein the first pressurizing element orthe second pressurizing element comprises a pump.

Embodiment 42

The system of Embodiment 14, wherein the atrial positioning structurecomprises a septal anchor configured for attachment to a septum of theheart of the patient.

Embodiment 43

The system of Embodiment 14, wherein the atrial positioning structurecomprises a left atrial appendage anchor or an anchoring memberconfigured for anchoring in an orifice of one or more pulmonary veins.

Embodiment 44

The system of Embodiment 14, wherein the pulmonary artery positioningstructure comprises an expandable cage disposed in-line with the secondpressurizing element.

Embodiment 45

The system of Embodiment 14, wherein the first pressurizing element,when operated, causes a volume displacement in the left atrium.

Embodiment 46

The system of Embodiment 45, wherein the second pressurizing element,when operated, causes a volume displacement in the pulmonary artery.

Embodiment 47

A method, comprising:

-   -   inflating a first balloon in a left atrium of a patient during a        first portion of each of multiple cardiac cycles for the        patient;    -   inflating a second balloon in a pulmonary artery of the patient        during a second portion of each of the cardiac cycles;    -   deflating the first balloon during a third portion of each of        the cardiac cycles; and    -   deflating the second balloon during a fourth portion of each of        the cardiac cycles.

Embodiment 48

The method of Embodiment 47, wherein the third portion and the fourthportion partially overlap, wherein the first portion and the secondportion partially overlap, and wherein the second portion and the thirdportion partially overlap.

Embodiment 49

A system, comprising:

-   -   a first implantable fluid-displacement element;    -   a first positioning structure coupled to the first implantable        fluid-displacement element and configured to position the first        implantable fluid-displacement element in fluid communication        with a portion of a left side of a heart of a patient;    -   a second implantable fluid-displacement element;    -   a second positioning structure coupled to the second implantable        fluid-displacement element and configured to position the second        implantable fluid-displacement element in fluid communication        with a portion of a right side of the heart; and    -   control circuitry configured for coordinated operation of the        first and second implantable fluid-displacement elements during        each cardiac cycle of the heart.

Embodiment 50

The system of Embodiment 49, wherein the first implantablefluid-displacement element comprises at least one of a pressurizingelement and a volume-displacement element.

Embodiment 51

The system of Embodiment 50, wherein the second implantablefluid-displacement element comprises at least one of a pressurizingelement and a volume-displacement element.

Embodiment 52

The system of Embodiment 49, wherein the first positioning structure isconfigured to position the first implantable fluid-displacement elementin a left atrium of the heart.

Embodiment 53

The system of Embodiment 52, wherein the second positioning structure isconfigured to position the second implantable fluid-displacement elementin a pulmonary artery of the patient or a right ventricle of the heartof the patient.

Embodiment 54

The system of Embodiment 49, wherein the first and second implantablefluid-displacement elements each comprise at least one of a balloon, apump, or a turbine.

Embodiment 55

The system of Embodiment 49, wherein the control circuitry is configuredto operate the first and second implantable fluid-displacement elementsresponsive to at least one sensor signal from a sensor that detectsportions of the cardiac cycle.

What is claimed is:
 1. A system for treating atrial dysfunction, the system comprising: a pressurizing element configured to be positioned in a left atrium of a heart of a patient; and control circuitry configured to: operate the pressurizing element to decrease a pressure in the left atrium and timed to coincide with atrial diastole to draw oxygenated blood out of the lungs of the patient by increasing a relative volume of the left atrium to reduce a filling pressure in the left atrium; and operate the pressurizing element to increase the pressure in the left atrium and timed to coincide with atrial systole by reducing the relative volume of the left atrium to increase a left atrial pressure during atrial systole, wherein the increase in the left atrial pressure during atrial systole increases a pressure differential between the left atrium and a left ventricle that improves diastolic filling of the left ventricle.
 2. The system of claim 1, further comprising an atrial positioning structure coupled to the pressurizing element and configured to position the pressurizing element in the left atrium.
 3. The system of claim 2, wherein the atrial positioning structure comprises a septal anchor or a left atrial appendage anchor.
 4. The system of claim 2, wherein the atrial positioning structure comprises a shaft configured to extend transseptally between a right atrium and the left atrium of the heart of the patient.
 5. The system of claim 4, wherein the shaft is pre-shaped with a curve or bend to facilitate positioning of the pressurizing element in the left atrium.
 6. The system of claim 4, wherein the system further comprises a shaped stylet configured to be delivered through the shaft to facilitate positioning of the pressurizing element in the left atrium.
 7. The system of claim 1, wherein the pressurizing element comprises a balloon, wherein operating the pressurizing element to increase the pressure in the left atrium comprises filling the balloon with a liquid or a gas, and wherein operating the pressurizing element to decrease the pressure in the left atrium comprises removing the liquid or the gas from the balloon.
 8. The system of claim 7, wherein a distal end of the balloon is recessed within the balloon such that the distal end of the balloon is atraumatic.
 9. The system of claim 7, wherein the balloon comprises an open central lumen.
 10. The system of claim 7, further comprising pressurizing components that include a pressure chamber and at least one pump disposed between the balloon and the pressure chamber.
 11. The system of claim 10, wherein the pressurizing components are configured to be external fixed, external ambulatory, or implantable components.
 12. The system of claim 2, wherein the atrial positioning structure comprises a septal anchor, wherein the septal anchor comprises first and second expandable members configured to expand respectively against left and right sides of an atrial septum of the heart of the patient, and wherein the pressurizing element is attached to the first expandable member.
 13. The system of claim 1, wherein the pressurizing element configured to be positioned in the left atrium is a first pressurizing element, and further comprising a second pressurizing element configured to be positioned in a pulmonary artery of the patient.
 14. The system of claim 13, further comprising a pulmonary artery positioning structure, wherein the second pressurizing element is coupled to the pulmonary artery positioning structure, the pulmonary artery positioning structure configured to position the second pressurizing element in the pulmonary artery of the patient.
 15. The system of claim 13, wherein the control circuitry is further configured to operate the first and second pressurizing elements to generate coordinated pressure modifications in the left atrium and the pulmonary artery.
 16. The system of claim 13, wherein the first pressurizing element comprises a first balloon, and the second pressurizing element comprises a second balloon.
 17. A method for treating atrial dysfunction, comprising: delivering a pressurizing element into a left atrium of a patient; operating the pressurizing element to decrease a pressure in the left atrium timed to coincide with atrial diastole to draw oxygenated blood out of the lungs of the patient by increasing a relative volume of the left atrium to reduce a filling pressure in the left atrium; and operating the pressurizing element to increase the pressure in the left atrium timed to coincide with atrial systole by reducing the relative volume of the left atrium to increase a left atrial pressure during atrial systole, wherein the increase in the left atrial pressure during atrial systole increases a pressure differential between the left atrium and left ventricle that improves diastolic filling of the left ventricle.
 18. The method of claim 17, wherein the pressurizing element is a balloon.
 19. The method of claim 17, further comprising: receiving, at control circuitry from a sensor communicatively coupled to the patient, a signal corresponding to a cardiac cycle for the heart of the patient; operating the pressurizing element to decrease a pressure in the left atrium responsive to a portion of the signal; and operating the pressurizing element to increase a pressure in the left atrium responsive to an additional portion of the signal.
 20. The method of claim 19, wherein the sensor comprises an electrical sensor or a pressure sensor.
 21. The method of claim 17, further comprising anchoring the pressurizing element within the left atrium.
 22. The method of claim 17, wherein the pressurizing element delivered into the left atrium is a first pressurizing element, and further comprising: delivering a second pressurizing element into a pulmonary artery of the patient; operating the second pressurizing element to decrease a pressure in the pulmonary artery during pulmonary artery systole to reduce pulmonary artery systolic pressures and reduce a work load of a right ventricle of the heart of the patient; and operating the second pressurizing element to increase a pressure in the pulmonary artery during pulmonary artery diastole after a pulmonary valve is closed to increase pulmonary artery diastolic pressure to overcome pulmonary vascular resistance and increase cardiac output. 